(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
34,000 Square Feet
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
78,685 Square Feet
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
26,453 Square Feet
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
2,777 Square Meters
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Share This 
Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This 
Summary Jim McNally’s article, ‘Overcoming bioanalytical hurdles in the pharma and life sciences sector,’ is now available in Manufacturing Chemist magazine: Click
Share This 
Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Share This 
Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This 
Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This 
Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure
Share This 
Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated
Share This 
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
34,000 Square Feet
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
78,685 Square Feet
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
26,453 Square Feet
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
2,777 Square Meters
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This Summary Jim McNally’s article, ‘Overcoming bioanalytical hurdles in the pharma and life sciences sector,’ is now available in Manufacturing Chemist magazine: Click
Share This Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Share This Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure
Share This Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated
Share This
Summary
A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment. This article discusses strategies for the development, optimization, and validation of NAb assays in relation to biosimilar and originator therapeutics.
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